(A) As used in this
chapter and all other rules promulgated pursuant to Chapter 3748. of the
Revised Code:
(1) "A
1"
means the maximum activity of special form radioactive material permitted in a
type A package. These values are listed in rule
3701:1-50-25
of the Administrative Code, or may be derived in accordance with the procedure
prescribed in rule
3701:1-50-25
of the Administrative Code.
(2)
"A
2" means the maximum activity of radioactive material,
other than special form, low specific activity and surface contaminated object
material, permitted in a type A package. These values are listed in rule
3701:1-50-25
of the Administrative Code, or may be derived in accordance with the procedure
prescribed in rule
3701:1-50-25
of the Administrative Code.
(3)
"Absorbed dose" means the energy imparted by ionizing radiation per unit mass
of irradiated material. The units of absorbed dose are the gray, or Gy, and the
rad.
(4) "Accelerator or charged
particle accelerator" means any of a class of radiation generating equipment
designed to electronically accelerate atomic or sub-atomic particles for
subsequent bombardment of targets.
(5) "Accelerator-produced radioactive
material" means any material made radioactive by a particle
accelerator.
(6) "Activity" means
the rate of disintegration or transformation or decay of radioactive material.
The units of activity are the becquerel, or Bq, and the curie, or Ci.
(7) "Address of use" means the building or
buildings that are identified on the license or registration and where the
source of radiation may be received, used, prepared, or stored, except for
temporary job sites.
(8)
"Administrative controls" means mechanisms used to protect health and minimize
damage to life and property through the use of written policies, procedures,
instructions, training, observation of work practices, and related compliance
audits.
(9) "Administrative
monetary penalty" means a monetary penalty assessed by the director under
section 3748.05 of the Revised Code and
in compliance with rules adopted thereunder, to emphasize the need for lasting
remedial action and to deter future violations.
(10) "Adult" means an individual eighteen or
more years of age.
(11) "Agreement
state" means any state with which the United States nuclear regulatory
commission or the atomic energy commission has entered into an effective
agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat.
919,
42 U.S.C.
2021, as amended (1978). Non-agreement state
means any other state.
(12)
"Airborne radioactive material" means radioactive material dispersed in the air
in the form of dusts, fumes, particulates, mists, vapors, or gases.
(13) "Airborne radioactivity area" means a
room, enclosure, or area in which airborne radioactive materials, composed
wholly or partly of licensed material, exist in concentrations:
(a) In excess of the derived air
concentrations (DACs) specified in appendix C to rule
3701:1-38-12
of the Administrative Code, or
(b)
To such a degree that an individual present in the area without respiratory
protective equipment could exceed, during the hours an individual is present in
a week, an intake of 0.6 per cent of the annual limit on intake or twelve
DAC-hours.
(14)
"Air-purifying respirator" means a respirator with an air-purifying filter,
cartridge, or canister that removes specific air contaminants by passing
ambient air through the air-purifying element.
(15) "ALARA" or "as low as is reasonably
achievable" means every reasonable effort to maintain exposures to radiation as
far below the dose limits as is practical consistent with the purpose for which
the licensed or registered activity is undertaken, taking into account the
state of technology, the economics of improvements in relation to benefits to
the public health and safety, and other societal and socioeconomic
considerations, and in relation to utilization of nuclear energy and licensed
materials and registered activities in the public interest.
(16) "Alert" means events may occur, are in
progress, or have occurred that could lead to a release of radioactive material
but that the release is not expected to require a response by off-site response
organizations to protect persons off-site.
(17) "Annual limit on intake" or "ALI" means
the derived limit for the amount of radioactive material taken into the body of
an adult worker by inhalation or ingestion in a year. ALI is the smaller value
of intake of a given radionuclide in a year by the reference man that would
result in a committed effective dose equivalent of 0.05 sievert (five rem) or a
committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or
tissue. ALI values for intake by ingestion and by inhalation of selected
radionuclides are given in appendix C to rule
3701:1-38-12
of the Administrative Code.
(18)
"Annually" means either
(a) At intervals not
to exceed one year; or
(b) Once per
year, at about the same time each year, plus or minus one month.
(19) "Area of use" means a portion
of an address of use that has been set aside for the purpose of receiving,
preparing, using, or storing sources of radiation.
(20) "Assigned protection factor" or "APF"
means the expected workplace level of respiratory protection that would be
provided by a properly functioning respirator or a class of respirators to
properly fitted and trained users. Operationally, the inhaled concentration can
be estimated by dividing the ambient airborne concentration by the
APF.
(21) "Atmosphere-supplying
respirator" means a respirator that supplies the respirator user with breathing
air from a source independent of the ambient atmosphere, and includes supplied
air respirators, or SARs, and self-contained breathing apparatus, or SCBA,
units.
(22) "Atomic energy
commission" or "AEC" means the federal agency created by the Atomic Energy Act
of 1954, 68 Stat.
919,
42 U.S.C.
2011, as amended (1964), and was the
predecessor agency to the current United States nuclear regulatory
commission.
(23) "Background
radiation" means radiation from cosmic sources; naturally occurring radioactive
materials, including radon, except as a decay product of source or special
nuclear material, and global fallout as it exists in the environment from the
testing of nuclear explosive devices or from past nuclear accidents such as
Chernobyl that contribute to background radiation and are not under the control
of the licensee. "Background radiation" does not include radiation from
radioactive materials regulated by the department.
(24) "Becquerel" or "Bq" means the SI unit of
activity. One becquerel is equal to one disintegration per second.
(25) "Bioassay" or "radiobioassay" means the
determination of kinds, quantities or concentrations, and, in some cases, the
locations of radioactive material in the human body, whether by direct
measurement, in vivo counting, or by analysis and evaluation of materials
excreted or removed from the human body.
(26) "Byproduct material" means
(a) Any radioactive material, except special
nuclear material, yielded in or made radioactive by exposure to the radiation
incident to the process of producing or utilizing special nuclear materials;
or
(b) The tailings or wastes
produced by the extraction or concentration of uranium or thorium from any ore
processed primarily for its source material content, including discrete surface
wastes resulting from solution extraction processes. Underground ore bodies
depleted by such solution extraction do not constitute byproduct material
within the definition.
(27) "Chelating agent" means a chemical
compound or mixture that enhances the removal of radioactive material from the
body, water or similar applications. Typical chelating agents include amine
polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and
polycarboxylic acids such as citric acid, carbolic acid, and gluconic
acid.
(28) "Chiropractor" means an
individual licensed by the state of Ohio to practice chiropractic medicine
pursuant to Chapter 4734. of the Revised Code.
(29) "Class" or "lung class" or "inhalation
class" means a classification scheme for inhaled material according to its rate
of clearance from the pulmonary region of the lung. Materials are classified as
D, W, or Y, which applies to a range of clearance half-times: for class D,
days, of less than ten days, for class W, weeks, from ten to one hundred days,
and for class Y, years, of greater than one hundred days.
(30) "Collective dose" means the sum of the
individual doses received in a given period of time by a specified population
from exposure to a specified source of radiation.
(31) "Commencement of construction" means
taking any action defined as "construction" or any other activity at the site
of a facility subject to the rules promulgated pursuant to Chapter 3748. of the
Revised Code that has a reasonable nexus to radiological health and
safety.
(32) "Committed dose
equivalent" or "HT,50" means the dose equivalent to
organs or tissues of reference, T, that will be received from an intake of
radioactive material by an individual during the fifty year period following
the intake.
(33) "Committed
effective dose equivalent" or "HE,50" means the sum of
the products of the weighting factors applicable to each of the body organs or
tissues, WT, that are irradiated and the committed dose
equivalent to each of these organs or tissues (HE, 50 =
WTHT,50).
(34) "Consortium" means an association of
medical use licensees and a PET radionuclide production facility in the same
geographical area that jointly own or share in the operation and maintenance
cost of the PET radionuclide production facility that produces PET
radionuclides for use in producing radioactive drugs within the consortium for
noncommercial distributions among its associated members for medical use. The
PET radionuclide production facility within the consortium must be located at
an educational institution or a medical facility.
(35) "Constraint" or "dose constraint" means
a value above which specified licensee actions are required.
(36) "Construction" means the installation of
foundations, or in-place assembly, erection, fabrication, or testing for any
structure, system, or component of a facility or activity subject to the rules
promulgated pursuant to Chapter 3748. of the Revised Code that are related to
radiological safety or security. The term "construction" does not include:
(a) Changes for temporary use of the land for
public recreational purposes;
(b)
Site exploration, including necessary borings to determine foundation
conditions or other preconstruction monitoring to establish background
information related to the suitability of the site, the environmental impacts
of construction or operation, or the protection of environmental
values;
(c) Preparation of the site
for construction of the facility, including clearing of the site, grading,
installation of drainage, erosion and other environmental mitigation measures,
and construction of temporary roads and borrow areas;
(d) Erection of fences and other access
control measures that are not related to the safe use of, or security of,
radiological materials subject to the rules promulgated pursuant to Chapter
3748. of the Revised Code;
(e)
Excavation;
(f) Erection of support
buildings (e.g. construction equipment storage sheds, warehouse and shop
facilities, utilities, concrete mixing plants, docking and unloading
facilities, and office buildings) for use in connection with the construction
of the facility;
(g) Building of
service facilities (e.g. paved roads, parking lots, railroad spurs, exterior
utility and lighting systems, potable water systems, sanitary sewerage
treatment facilities, and transmission lines);
(h) Procurement or fabrication of components
or portions of the proposed facility occurring at other than the final,
in-place location at the facility; or
(i) Taking any other action that has no
reasonable nexus to radiological health and safety.
(37) "Controlled area" means an area, outside
of a restricted area but inside the site boundary, access to which can be
limited by the licensee or registrant for any reason.
(38) "Critical group" means the group of
individuals reasonably expected to receive the greatest exposure to residual
radioactivity for any applicable set of circumstances.
(39) "Curie" or "Ci" means a unit of
activity. One curie equals 3.7 x 1010
disintegrations per second equals 3.7 x 1010
becquerels equals 2.22 x 1012 disintegrations per
minute.
(40) "Cyclotron" means a
particle accelerator in which the charged particles travel in an outward spiral
or circular path. A cyclotron accelerates charged particles at energies usually
in excess of ten megaelectron volts and is commonly used for production of
short half-life radionuclides for medical use.
(41) "Declared pregnant woman" means a woman
who has voluntarily informed the licensee or registrant, in writing, of her
pregnancy and the estimated date of conception. The declaration remains in
effect until the declared pregnant woman withdraws the declaration in writing
or is no longer pregnant.
(42)
"Decommission" means to safely remove any licensed operation from service and
reduce residual radioactivity to a level that permits release of the licensee's
property for unrestricted use and termination of the license.
(43) "Dedicated check source" means a
radioactive source that is used to assure the consistent performance of a
radiation detection or measurement device over several months or
years.
(44) "Deep dose equivalent"
or "Hd" applies to external whole body exposure, and
means the dose equivalent at a tissue depth of one centimeter, one thousand
milligram per square centimeter.
(45) "Demand respirator" means an
atmosphere-supplying respirator that admits breathing air to the facepiece only
when a negative pressure is created inside the facepiece by
inhalation.
(46) "Dentist" means an
individual licensed by the state of Ohio to practice dentistry under Chapter
4715. of the Revised Code.
(47)
"Department" means the Ohio department of health.
(48) "Depleted uranium" means uranium
containing less uranium-235 than the naturally occurring distribution of
uranium isotopes.
(49) "Derived air
concentration" or "DAC" means the concentration of a given radionuclide in air
which, if breathed by the reference man for a working year of two thousand
hours under conditions of light work, results in an intake of one ALI. The
condition of light work is inhaling 1.2 cubic meters of air per hour for two
thousand hours in a year. DAC values are given in appendix C to rule
3701:1-38-12
of the Administrative Code.
(50)
"Derived air concentration-hour or DAC-hour" means the product of the
concentration of radioactive material in air, which is expressed as a fraction
or multiple of the derived air concentration for each radionuclide, and the
time of exposure to that radionuclide, in hours. A licensee or registrant may
take two thousand DAC-hours to represent one ALI, equivalent to a committed
effective dose equivalent of 0.05 Sv (five rem).
(51) "Direct reading dosimeter" means a
device that measures radiation dose that does not require another device to
read the measured radiation dose. Examples of direct reading dosimeters include
pocket dosimeters and electronic dosimeters.
(52) "Director" means the director of health
or a designee or authorized representative of the director.
(53) "Discipline" means a branch of knowledge
or of teaching.
(54) "Discrete
source" means a radionuclide that has been processed so that its concentration
within a material has been purposely increased for use for commercial, medical,
or research activities.
(55)
"Disposable respirator" means a respirator for which maintenance is not
intended and that is designed to be discarded after excessive breathing
resistance, sorbent exhaustion, physical damage, or end-of service-life renders
it unsuitable for use. Examples of this type of respirator are a disposable
half-mask respirator or a disposable escape-only self-contained breathing
apparatus.
(56) "Dose" or
"radiation dose" is a generic term that means absorbed dose, dose equivalent,
effective dose equivalent, committed effective dose equivalent, or total
effective dose equivalent as defined in other paragraphs of this
rule.
(57) "Dose equivalent" or
"HT" means the product of the absorbed dose in tissue,
quality factor, and all other necessary modifying factors at the location of
interest. The units of dose equivalent are the sievert and rem.
(58) "Dose limits" or "limits" means the
permissible upper bounds of radiation doses established in accordance with
these regulations but excludes background radiation and medical
exposure.
(59) "Dosimetry
processor" means a person that processes and evaluates individual monitoring
devices in order to determine the radiation dose delivered to the monitoring
devices.
(60) "Effective dose
equivalent" or "HE" means the sum of the products of the
dose equivalent to each organ or tissue, HT, and the
weighting factor, WT, applicable to each of the body
organs or tissues that are irradiated: (HE =
[SIGMA]WTHT).
(61) "Embryo" or "fetus" means the developing
human organism from conception until time of birth.
(62) "Engineering controls" means mechanisms
used to protect health and minimize damage to life and property through
engineering specifications, design, and construction of the product or facility
including all of the security and safety features. This includes, but is not
limited to, auxiliary security and safety features such as additional external
shielding, barriers, and operational interlocks with associated
processes.
(63) "Entrance" or
"access point" means any opening through which an individual or extremity of an
individual could gain access to radiation areas or to licensed radioactive
materials or registered radiation generating equipment. This includes entry or
exit portals of sufficient size to permit human entry, irrespective of their
intended use.
(64) "Explosive
material" means any chemical compound, mixture or device which produces a
substantial instantaneous release of gas and heat spontaneously or by contact
with sparks or flame.
(65)
"Exposure" means being exposed to sources of ionizing radiation.
(66) "External dose" means that portion of
the dose equivalent received from radiation sources outside the body.
(67) "Extremity" means hand, elbow, arm below
the elbow, foot, knee, or leg below the knee.
(68) "Eye dose equivalent" means the same as
lens dose equivalent.
(69)
"Facility" means all buildings, equipment, structures and other stationary
items that, in addition to the meaning defined in division (H) of section
3748.01 of the Revised Code,
are:
(a) Located on a single site or on
contiguous or adjacent sites and are operated by the same person and have
common corporate or business interests; or
(b) Portions of a building or structure which
are operated by the same person and have common corporate or business
interests.
(70)
"Filtering facepiece" or "dust mask" means a negative pressure particulate
respirator with a filter as an integral part of the facepiece or with the
entire facepiece composed of the filtering medium, not equipped with
elastomeric sealing surfaces and adjustable straps.
(71) "Fissile material" means the
radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or
any combination of these radionuclides. Fissile material means the fissile
nuclides themselves, not material containing fissile nuclides. Unirradiated
natural uranium and depleted uranium and natural uranium or depleted uranium
that has been irradiated in thermal reactors only, are not included in this
definition. Certain exclusions from fissile material controls are provided in
rule
3701:1-50-13
of the Administrative Code.
(72)
"Fit factor" means quantitative estimate of the fit of a particular respirator
to a specific individual, and typically estimates the ratio of the
concentration of a substance in ambient air to its concentration inside the
respirator when worn.
(73) "Fit
test" means the use of a protocol to qualitatively or quantitatively evaluate
the fit of a respirator on an individual.
(74) "Generally applicable environmental
radiation standards" means standards issued by the United States environmental
protection agency under the authority of the Atomic Energy Act of 1954, 68
Stat.
919,
42 U.S.C.
2011, as amended (2005), that impose limits
on radiation exposures or levels, or concentrations or quantities of
radioactive material, in the general environment outside the boundaries of
locations under the control of persons possessing or using radioactive
material.
(75) "Gray" or "Gy" means
the SI unit of absorbed dose. One gray is equal to an absorbed dose of one
joule per kilogram (one hundred rads).
(76)
"Handle" means
receive, possess, use, store, transfer, install, service, or dispose of sources
of radiation unless possession is solely for the purpose of
transportation.
(76)(77) "Handler" means a
facility that handles sources of radiation unless possession is solely for the
purpose of transportation.
(77)(78) "Hazardous waste"
means those wastes designated as hazardous by rule
3745-51-03
of the Administrative Code.
(78)(79) "Helmet" means a
rigid respiratory inlet covering that also provides head protection against
impact and penetration.
(79)(80) "High radiation
area" means an area, accessible to individuals, in which radiation levels from
radiation sources external to the body could result in an individual receiving
a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty
centimeters from the radiation source or thirty centimeters from any surface
that the radiation penetrates.
(80)(81) "Hood" means a
respiratory inlet covering that completely covers the head and neck and may
also cover portions of the shoulders and torso.
(81)(82) "Individual"
means any human being.
(82)(83) "Individual
monitoring" means
(a) The assessment of dose
equivalent by the use of devices designed to be worn by an
individual;
(b) The assessment of
committed effective dose equivalent by bioassay or by determination of the
time-weighted air concentrations to which an individual has been exposed, i.e.
DAC-hours; or
(c) The assessment of
dose equivalent by the use of survey data.
(83)(84)
"Individual monitoring devices" means devices designed to be worn by a single
individual for the assessment of dose equivalent such as film badges;
thermoluminescent dosimeters; optically stimulated luminescent dosimeters;
pocket ionization chambers; and personal air sampling devices.
(84)(85)
"Industrial radiography" means the examination of the structure of materials by
nondestructive methods, utilizing sealed sources of radioactive material or
radiation-generating equipment.
(85)(86) "Internal dose"
means that portion of the dose equivalent received from radioactive material
taken into the body.
(86)(87) "Irradiator"
means a facility that uses radioactive sealed sources for the irradiation of
objects or materials and in which radiation dose rates exceeding five grays
(five hundred rads) per hour exist at one meter from the sealed radioactive
source in air or water, as applicable for the irradiator type, but does not
include irradiators in which both the sealed source and the area subject to
irradiation are contained within a device and are not accessible to
personnel.
(87)(88) "Lens dose
equivalent" or "eye dose equivalent" means the external exposure of the lens of
the eye and is taken as the dose equivalent at a tissue depth of 0.3
centimeters; i.e. three hundred milligrams per square centimeter.
(88)(89)
"License" means a license issued by the nuclear regulatory commission, the
director, or another agreement state in accordance with rules adopted by those
organizations.
(89)(90) "Licensee" means
a person to whom a license is issued.
(90)(91) "Licensed
activity" means an activity authorized by a radioactive material license which
is essential to achieving the purpose for which the license was issued or
amended.
(91)(92) "Licensed
material" means radioactive material received, possessed, used, transferred or
disposed of under a general or specific license.
(92)(93) "Loose-fitting
facepiece" means a respiratory inlet covering that is designed to form a
partial seal with the face.
(93)(94) "Lost or missing
licensed source of radiation" means a licensed source of radiation whose
location is unknown. It includes material that has been shipped but has not
reached its destination and whose location cannot be readily traced in the
transportation system.
(94)(95) "Low-level
radioactive waste" or "LLRW," also "low-level waste," or "LLW" means
radioactive waste which is not high-level radioactive waste, spent nuclear
fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic
Energy Act of 1954 68 Stat.
919,
42 U.S.C.
2011, as amended (2005), but is radioactive
material that the United States nuclear regulatory commission classifies as
low-level radioactive waste.
(95)(96) "Low specific
activity material" or "LSA" means radioactive material with limited specific
activity which is nonfissile or is excepted under rule
3701:1-50-13
of the Administrative Code, and which satisfies the descriptions and limits set
forth below. Shielding materials surrounding the LSA material may not be
considered in determining the estimated average specific activity of the
package contents. LSA must be in one of three groups:
(a) LSA - I.
(i) Uranium and thorium ores, concentrates of
uranium and thorium ores, and other ores containing naturally occurring
radioactive radionuclides that are intended to be processed for the use of
these radionuclides;
(ii) Natural
uranium, depleted uranium, natural thorium or their compounds or mixtures,
provided they are unirradiated and in solid or liquid form;
(iii) Radioactive material other than fissile
material, for which the A2 value is unlimited;
or
(iv) Other radioactive material
in which the activity is distributed throughout and the estimated average
specific activity does not exceed thirty times the value for exempt material
activity concentration determined in accordance with rule
3701:1-50-25
of the Administrative Code.
(b) LSA-II.
(i) Water with tritium concentration up to
0.8 terabecquerels per liter (twenty curies per liter); or
(ii) Other material in which the activity is
distributed throughout and the estimated average specific activity does not
exceed ( 10-4 A2) per gram
for solids and gases, and (10-5
A2) per gram for liquids.
(c) LSA-III. Solids (e.g., consolidated
wastes, activated materials), excluding powders, that satisfy the requirements
of
10 C.F.R.
71.77 (
as
published in the January 1, 2017, Code of Federal Regulations
as in effect on the effective date of this rule), in
which:
(i) The radioactive material is
distributed throughout a solid or a collection of solid objects, or is
essentially uniformly distributed in a solid compact binding agent (such as
concrete, bitumen, ceramic, etc.);
(ii) The radioactive material is relatively
insoluble, or it is intrinsically contained in a relatively insoluble material,
so that even under loss of packaging, the loss of radioactive material per
package by leaching, when placed in water for seven days, would not exceed (0.1
x A2); and
(iii) The estimated average specific activity
of the solid, excluding any shielding material, does not exceed (0.002 x
A2) per gram.
(96)(97)
"Management" means the chief executive officer or other individual having the
authority to manage, direct, or administer the licensee's activities, or those
persons' delegate or delegates.
(97)(98) "Medical
institution" means an organization in which more than one medical discipline is
practiced.
(98)(99) "Medical use"
means the intentional internal or external administration of radioactive
material or the radiation therefrom to patients or human research subjects
under the supervision of an authorized user.
(99)(100) "Member of the
public" means any individual except when that individual is receiving an
occupational dose.
(100)(101) "Minor" means
an individual less than eighteen years of age.
(101)(102) "Monitoring" or
"radiation monitoring" or "radiation protection monitoring" means the
measurement of radiation levels, concentrations, surface area concentrations or
quantities of radioactive material and the use of the results of these
measurements to evaluate potential exposures and doses.
(102)(103) "NARM" or
"naturally occurring or accelerator-produced radioactive material" means
naturally occurring or accelerator-produced radioactive material, including
naturally occurring material that is technologically enhanced, and those
nuclides that are generated in a charged particle accelerator, but does not
include source material, byproduct material, or special nuclear
material.
(103)(104) "NARM licensing
state" means any state with regulations equivalent to the suggested state
regulations for control of radiation relating to, and an effective program for,
the regulatory control of NARM and which has been granted final designation by
the conference of radiation control program directors, inc.
(104)(105) "Nationally
tracked source" means a sealed source containing a quantity equal to or greater
than "Category 1" or "Category 2" levels of any radioactive material listed in
the appendix to rule
3701:1-38-25
of the Administrative Code. In this context a sealed source is defined as
radioactive material that is sealed in a capsule or closely bonded, in a solid
form and which is not exempt from regulatory control. It does not mean material
encapsulated solely for disposal, or nuclear material contained in any fuel
assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally
tracked sources are those containing radioactive material at a quantity equal
to or greater than the "Category 1" threshold. "Category 2" nationally tracked
sources are those containing radioactive material at a quantity equal to or
greater than the "Category 2" threshold but less than the "Category 1"
threshold.
(105)(106) "Negative
pressure respirator" or "tight fitting respirator" means a respirator in which
the air pressure inside the facepiece is negative during inhalation with
respect to the ambient air pressure outside the respirator.
(106)(107) "Nonstochastic
effect" or "deterministic effect" means health effects, the severity of which
varies with the dose and for which a threshold is believed to exist.
Radiation-induced cataract formation is an example of a nonstochastic
effect.
(107)(108) "NORM" or
"naturally occurring radioactive material" means any nuclide that is
radioactive in its natural physical state, but does not include source
material, byproduct material, or special nuclear material.
(108)(109) "Normal form
radioactive material" means radioactive material that has not been demonstrated
to qualify as special form radioactive material.
(109)(110) "Nuclear
regulatory commission" means the federal agency established by Title II of the
Energy Reorganization Act of 1974, 88 Stat.
1233,
42 U.S.C.A.
5801, as amended (2005), comprising the
members of the commission and all offices, employees, and representatives
authorized to act in any case or matter related to licensing and related
regulatory function previously assigned to the AEC.
(110)(111) "Occupational
dose" means the dose received by an individual in the course of employment in
which the individual's assigned duties involve exposure to radiation or
radioactive material from licensed and unlicensed sources of radiation, whether
in the possession of the licensee or other person. Occupational dose does not
include doses received from background radiation, from any medical
administration the individual has received, from exposures to individuals
administered radioactive materials and released in accordance with rule
3701:1-58-30
of the Administrative Code or equivalent United States nuclear regulatory
commission or agreement state regulations, from voluntary participation in
medical research programs, or as a member of the public.
(111)(112) "Package" means
the packaging together with its radioactive contents as presented for
transport.
(a) Fissile material package or
type AF package, type BF package, type B(U)F package, or type B(M)F package
means a fissile material packaging together with its fissile material
contents.
(b) Type A package means
a type A packaging together with its radioactive contents. A type A package is
defined and must comply with the United States department of transportation
regulations in 49 C.F.R.
173 (
as published in the
October 1, 2014, Code of Federal Regulations
as
in effect on the effective date of this rule).
(c) Type B package means a type B packaging
together with its radioactive contents. On approval, a type B package design is
designated by the United States nuclear regulatory commission as B(U) unless
the package has a maximum normal operating pressure of more than seven hundred
kilopascals (one hundred pounds per square inch) gauge or a pressure relief
device that would allow the release of radioactive material to the environment
under the tests specified in
10 C.F.R.
71.73 (hypothetical accident conditions)
(
as published in the January 1, 2015, Code of
Federal Regulations
as in effect on the
effective date of this rule), in which case it will receive a designation
B(M). B(U) refers to the need for unilateral approval of international
shipments; B(M) refers to the need for multilateral approval of international
shipments. There is no distinction made in how packages with these designations
may be used in domestic transportation. To determine their distinction for
international transportation, see United States department of transportation
regulations in 49 C.F.R.
173 (
as published in the
October 1, 2014 Code of Federal Regulations
as
in effect on the effective date of this rule). A type B package approved
before September 6, 1983, was designated only as type B. Limitations on its use
are specified in
10 C.F.R.
71.19 (
as
published in the January 1, 2015, Code of Federal Regulations
as in effect on the effective date of this
rule).
(112)(113) "Packaging"
means the assembly of components necessary to ensure compliance with the
packaging requirements of rule 49 C.F.R.
173 Subpart I (
as published in the October 1, 2014, Code of Federal
Regulations
as in effect on the effective date
of this rule). It may consist of one or more receptacles, absorbent
materials, spacing structures, thermal insulation, radiation shielding, and
devices for cooling or absorbing mechanical shocks. The vehicle, tie-down
system and auxiliary equipment may be designated as part of the
packaging.
(113)(114) "Particle
accelerator" means any machine capable of accelerating electrons, protons,
deuterons, or other charged particles in a vacuum and of discharging the
resultant particulate or other radiation into a medium at energies usually in
excess of one megaelectron volt. For purposes of this definition, "accelerator"
is an equivalent term.
(114)(115) "Person" means
any individual, corporation, association, business enterprise, or other legal
entity either public or private and any legal successor, representative, agent,
or agency of that individual, corporation, association, business enterprise, or
other legal entity. Person also includes the United States, states, political
subdivisions of states, and any department, agency, or instrumentality of the
United States or a state, except the U.S. department of energy or the U.S.
nuclear regulatory commission where the state regulation of radioactive
material by either of those agencies is prohibited by federal law.
(115)(116) "Personnel
dosimeter", means a device that measures radiation dose that is processed and
evaluated by an accredited "National Voluntary Laboratory Accreditation
Program" (NVLAP) processor. Examples of personnel dosimeters include film
badges, thermo-luminescent dosimeters (TLD), and optically stimulated
luminescence (OSL) dosimeters.
(116)(117) "Pharmacist"
means a person who is licensed by the state of Ohio to practice pharmacy
pursuant to Chapter 4731. of the Revised Code.
(117)(118) "Physician"
means a person who is licensed pursuant to Chapter 4731. of the Revised Code to
practice medicine or surgery or osteopathic medicine or surgery.
(118)(119) "Planned
special exposure" means an infrequent exposure to radiation, separate from and
in addition to the annual dose limits.
(119)(120) "Podiatrist"
means an individual licensed by the state of Ohio to practice podiatry pursuant
to Chapter 4731. of the Revised Code.
(120)(121) "Positive
pressure respirator" means a respirator in which the pressure inside the
respiratory inlet covering exceeds the ambient air pressure outside the
respirator.
(121)(122) "Positron
Emission Tomography (PET) radionuclide production facility" means a facility
operating a cyclotron or accelerator for the purpose of producing PET
radionuclides.
(122)(123) "Powered
air-purifying respirator" or "PAPR" means an air-purifying respirator that uses
a blower to force the ambient air through air purifying elements to the inlet
covering.
(123)(124) "Pressure
demand respirator" means a positive pressure atmosphere supplying respirator
that admits breathing air to the facepiece when the positive pressure is
reduced inside the facepiece by inhalation.
(124)(125) "Public dose"
means the dose received by a member of the public from exposure to radiation
and/or radioactive material released by the licensee, or to any other source of
radiation under the control of a licensee or registrant. Public dose does not
include occupational dose or doses received from background radiation, from any
medical administration the individual has received, from exposures to
individuals administered radioactive materials and released in accordance with
rule
3701:1-58-30
of the Administrative Code or equivalent United States nuclear regulatory
commission or agreement state regulations, or from voluntary participation in
medical research programs.
(125)(126) "Pyrophoric
material" means any liquid that ignites spontaneously in dry or moist air at or
below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A
pyrophoric solid is any solid material, other than one classed as an explosive,
which under normal conditions is liable to cause fires through friction,
retained heat from manufacturing or processing, or which can be ignited readily
and when ignited burns so vigorously and persistently as to create a serious
transportation, handling, or disposal hazard. Included are spontaneously
combustible and water-reactive materials.
(126)(127) "Qualitative
fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of
respirator fit that relies on the individual's response to the test
agent.
(127)(128) "Quality
factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B)
of rule
3701:1-38-11
of the Administrative Code, that is used to derive dose equivalent from
absorbed dose.
(128)(129) "Quantitative
fit test" or "QNFT" means an assessment of the adequacy of respirator fit by
numerically measuring the amount of leakage into the respirator.
(129)(130) "Quarter" or
"quarterly" means a period of time equal to one-fourth of the year observed by
the licensee or registrant, approximately thirteen consecutive weeks, providing
that the beginning of the first quarter in a year coincides with the starting
date of the year and that no day is omitted or duplicated in consecutive
quarters.
(130)(131) "Rad" means the
special unit of radiation absorbed dose. One rad is equal to an absorbed dose
of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01
gray.
(131)(132) "Radiation" or
"ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays,
neutrons, high speed electrons, high speed protons, and other particles capable
of producing ions. Radiation does not include nonionizing radiation, such as
radio or microwaves, or visible, infrared or ultraviolet light.
(132)(133) "Radiation
area" means an area, accessible to individuals, in which radiation levels could
result in an individual receiving a dose equivalent in excess of 0.05
millisievert (0.005 rem) in one hour at thirty centimeters from the source of
radiation or from any surface that the radiation penetrates.
(133)(134)
"Radiation-generating equipment" or "RGE" means any manufactured product or
device, or component of such a product or device, or any machine or system that
during operation can generate or emit radiation, except those that emit
radiation only from radioactive material. "Radiation-generating equipment" does
not include either of the following:
(a)
Diathermy machines;
(b) Microwave
ovens, including food service microwave ovens used for commercial and
industrial uses, television receivers, electric lamps, and other household
appliances and products that generate very low levels of radiation.
(134)(135) "Radiation
Safety Officer" or "RSO" means an individual designated by the licensee who has
the knowledge and responsibility for the overall radiation safety program at
the facility, to include the implementation of the daily radiation safety
operations and compliance with the rules.
(135)(136) "Radioactive
material" means any solid, liquid or gaseous material that emits ionizing
radiation spontaneously. "Radioactive material" includes accelerator-produced
and naturally occurring radioactive materials and byproduct, source, and
special nuclear material.
(136)(137) "Radioactive
waste" means waste containing regulated radioactive material.
(137)(138) "Radioactivity"
means the transformation of unstable atoms by the emission of
radiation.
(138)(139) "Radiography"
means the same as industrial radiography.
(139)(140) "Reference man"
means a hypothetical aggregation of human physical and physiological
characteristics arrived at by international consensus. These characteristics
may be used by researchers and public health workers to standardize results of
experiments and to relate biological insult to a common base.
(140)(141) "Registrant"
means a person required by Chapter 3748. of the Revised Code to register
radiation-generating equipment with the director.
(141)(142) "Rem" means the
special unit of any of the quantities expressed as dose equivalent. The dose
equivalent in rem is equal to the absorbed dose in rads multiplied by the
quality factor (one rem = 0.01 Sv).
(142)(143) "Research and
development" means
(a) Theoretical analysis,
exploration, or experimentation; or
(b) The extension of investigative findings
and theories of a scientific or technical nature into practical application for
experimental and demonstration purposes, including the experimental production
and testing of models, devices, equipment, materials and processes. "Research
and development" does not include the internal or external administration of
sources of radiation to human beings.
(143)(144) "Residual
radioactivity" means radioactivity in structures, materials, soils,
groundwater, and other media at a site resulting from activities under the
licensee's control. This includes radioactivity from all licensed and
unlicensed sources used by the licensee, but excludes background radiation. It
also includes radioactive materials remaining at the site as a result of
routine or accidental releases of radioactive material at the site and previous
burials at the site, even if those burials were made in accordance with the
provisions of 10 C.F.R.
20 (
as published in the
January 1, 2015, Code of Federal Regulations
as
in effect on the effective date of this rule).
(144)(145) "Respiratory
protective equipment or device" means an apparatus, such as a respirator, used
to reduce the individual's intake of airborne radioactive materials.
(145)(146) "Restricted
area" means an area access to which is limited by the licensee or registrant
for the purpose of protecting individuals against undue risks from exposure to
sources of radiation. Restricted area does not include areas used as
residential quarters, but separate rooms in a residential building may be set
apart as a restricted area.
(146)(147) "Roentgen"
means the amount of gamma or x-rays required to produce ions resulting in a
charge of 0.000258 coulombs per kilogram of air under standard
conditions.
(147)(148) "Sanitary
sewerage" means a system of public sewers for carrying off wastewater and
refuse, but excluding sewage treatment facilities, septic tanks, and leach
fields owned or operated by the licensee.
(148)(149) "Sealed source"
means radioactive material that is encased in a manner designed to prevent
leakage or escape of the radioactive material.
(149)(150) "Sealed source
and device registry" means the national registry that contains all the
registration certificates, generated by both the United States nuclear
regulatory commission and the agreement states, that summarize the radiation
safety information for the sealed sources and devices and describe the
licensing and use conditions approved for the product.
(150)(151) "Seismic area"
means any area where the probability of a horizontal acceleration in rock of
more than 0.3 times the acceleration of gravity in two hundred fifty years is
greater than ten per cent, as designated by the United States geological
survey.
(151)(152) "Self-contained
breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for
which the breathing air source is designed to be carried by the user.
(152)(153) "Shallow dose
equivalent" or "HS" means the external exposure of the
skin of the whole body or the skin of an extremity, is taken as the dose
equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per
square centimeter.
(153)(154) "Sievert" or
"Sv" means the SI unit of any of the quantities expressed as dose equivalent.
The dose equivalent in sieverts is equal to the absorbed dose in grays
multiplied by the quality factor. One sievert equals one hundred rem.
(154)(155) "Site area
emergency" means events may occur, are in progress, or have occurred that could
lead to a significant release of radioactive material and that could require a
response by off-site response organizations to protect persons
off-site.
(155)(156) "Site boundary"
means that line beyond which the land or property is not owned, leased, or
otherwise controlled by the licensee or registrant.
(156)(157) "Site closure
and stabilization" means those actions that are taken upon completion of
operations that prepare a disposal site for custodial care and that assure that
the disposal site will remain stable and will not need ongoing active
maintenance.
(157)(158) "Source
material" means uranium, thorium, or any combination thereof in any physical or
chemical form, or any ores that contain by weight at least one-twentieth of one
per cent (0.05 per cent) of uranium, thorium, or any combination thereof.
Source material does not include special nuclear material.
(158)(159) "Sources of
radiation" means radioactive material or radiation generating
equipment.
(159)(160) "Special form
radioactive material" means radioactive material that satisfies the following
conditions:
(a) It is either a single solid
piece or is contained in a sealed capsule that can be opened only by destroying
the capsule;
(b) The piece or
capsule has at least one dimension not less than five millimeters (0.2 inch);
and
(c) It satisfies the test
requirements specified by the United States nuclear regulatory commission in
10 C.F.R.
71.75 (
as
published in the January 1, 2017,
Code of
Federal Regulations
as in effect on the
effective date of this rule). A special form encapsulation designed in
accordance with the United States nuclear regulatory commission requirements
identified in
10
C.F.R.
71.4, in effect on June 30, 1983, and
constructed prior to July 1, 1985; a special form encapsulation designed in
accordance with the requirements of
10
C.F.R.
71.4 in effect on March 31, 1996, and
constructed before April 1, 1998; and special form material that was
successfully tested before September 10, 2015 in accordance with the
requirements of
10 C.F.R.
71.75(d) of this section in
effect before September 10, 2015 may continue to be used. Any other special
form encapsulation must meet the specifications of this definition.
(160)(161) "Special
nuclear material" means either of the following:
(a) Plutonium, uranium-233, uranium enriched
in the isotope 233, or in the isotope 235, and any other material that the
United States nuclear regulatory commission determines to be special nuclear
material, but does not include source material pursuant to section 51 of the
Atomic Energy Act of 1954, 68 Stat 919,
42 USCA 2071, as amended
(2005).
(b) Any material
artificially enriched by any of the foregoing but does not include source
material.
(161)(162) "Special
nuclear material in quantities not sufficient to form a critical mass" means
uranium enriched in the isotope uranium-235 in quantities not exceeding three
hundred fifty grams of contained uranium-235; uranium-233 in quantities not
exceeding two hundred grams; plutonium in quantities not exceeding two hundred
grams; or any combination of them in accordance with the following formula: for
each kind of special nuclear material, determine the ratio between the quantity
of that special nuclear material and the quantity specified in this paragraph
for the same kind of special nuclear material. The sum of such ratios for all
of the kinds of special nuclear material in combination shall not exceed
unity.
(162)(163) "Stochastic
effect" means health effects that occur randomly and for which the probability
of the effect occurring, rather than its severity, is assumed to be a linear
function of dose without threshold. Hereditary effects and cancer incidence are
examples of stochastic effects.
(163)(164) "Supplied-air
respirator" or "SAR" or "airline respirator" means an atmosphere-supplying
respirator for which the source of breathing air is not designed to be carried
by the user.
(164)(165) "Surface
contaminated object" or "SCO" means a solid object that is not itself classed
as radioactive material, but which has radioactive material distributed on any
of its surfaces. SCO must be in one of two groups with surface activity not
exceeding the following limits:
(a) SCO-I: a
solid object on which:
(i) The non-fixed
contamination on the accessible surface averaged over three hundred square
centimeters, or the area of the surface if less than three hundred square
centimeters, does not exceed four becquerels per square centimeter
(10-4 microcurie per square centimeter) for beta and
gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter
10-5 microcurie per square centimeter) for all other
alpha emitters;
(ii) The fixed
contamination on the accessible surface averaged over three hundred square
centimeters, or the area of the surface if less than three hundred square
centimeters, does not exceed forty thousand becquerels per square centimeter
(one microcurie per square centimeter) for beta and gamma and low toxicity
alpha emitters, or four thousand becquerels per square centimeter (0.1
microcurie per square centimeter) for all other alpha emitters; and
(iii) The non-fixed contamination plus the
fixed contamination on the inaccessible surface averaged over three hundred
square centimeters, or the area of the surface if less than three hundred
square centimeters, does not exceed forty thousand becquerels per square
centimeter (one microcurie per square centimeter) for beta and gamma and low
toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1
microcurie per square centimeter) for all other alpha emitters.
(b) SCO-II: a solid object on
which the limits for SCO-I are exceeded and on which:
(i) The non-fixed contamination on the
accessible surface averaged over three hundred square centimeters, or the area
of the surface if less than three hundred square centimeter, does not exceed
four hundred becquerels per square centimeter (10-2
microcurie per square centimeter) for beta and gamma and low toxicity alpha
emitters, or forty becquerels per square centimeter
(10-3 microcurie per square centimeter) for all
other alpha emitters;
(ii) The
fixed contamination on the accessible surface averaged over three hundred
square centimeters, or the area of the surface if less than three hundred
square centimeters, does not exceed eight hundred thousand becquerels per
square centimeter (twenty microcuries per square centimeter) for beta and gamma
and low toxicity alpha emitters, or eighty thousand becquerels per square
centimeter (two microcuries per square centimeter) for all other alpha
emitters; and
(iii) The non-fixed
contamination plus the fixed contamination on the inaccessible surface averaged
over three hundred square centimeters, or the area of the surface if less than
three hundred square centimeters, does not exceed eight hundred thousand
becquerels per square centimeter (twenty microcuries per square centimeter) for
beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels
per square centimeter (two microcuries per square centimeter) for all other
alpha emitters.
(165)(166) "Survey" means
an evaluation of the radiological conditions and potential hazards incident to
the production, use, transfer, release, disposal or presence of radioactive
material or other sources of radiation. When appropriate, such an evaluation
includes a physical survey of the location of radioactive material, or the
sources of radiation and measurements or calculations of levels of radiation,
or concentrations or quantities of radioactive material present.
(166)(167) "Tight-fitting
facepiece" means a respiratory inlet covering that forms a complete seal with
the face.
(167)(168) "Total
effective dose equivalent" or "TEDE" means the sum of the effective dose
equivalent (for external exposures) and the committed effective dose equivalent
(for internal exposures).
(168)(169) "Transport
index" means the dimensionless number, rounded up to the next tenth, placed on
the label of a package, to designate the degree of control to be exercised by
the carrier during transportation. The transport index is the number determined
by multiplying the maximum radiation level in millisievert per hour at one
meter (3.3 feet) from the external surface of the package by one hundred, which
is equivalent to the maximum radiation level in millirem per hour at one meter
(3.3 feet).
(169)(170) "Type A
quantity" means a quantity of radioactive material, the aggregate radioactivity
of which does not exceed A
1 for special form radioactive
material, or A
2 for normal form radioactive material,
where A
1 and A
2 are given in rule
3701:1-50-25
of the Administrative Code.
(170)(171) "Type B
quantity" means a quantity of radioactive material greater than a type A
quantity.
(171)(172) "Type B
package" is defined under "Package."
(172)(173) "United States
department of energy" means the department of energy established by the
Department of Energy Organization Act, PL 95-91, 91 Stat.
565 (1977),
42
U.S.C.
7101 et seq., as amended (2006), to
the extent that the department of energy or its duly authorized
representatives, exercises functions formerly vested in the United States
atomic energy commission, its chairman, members, officers and components and
transferred to the United States energy research and development administration
and to the administrator thereof pursuant to Sections 104(b) to (d) of the
Energy Reorganization Act of 1974, PL 93-438, 88 Stat.
1233 at 1237 (1974),
42 U.S.C.
5814 and retransferred to the secretary of
energy pursuant to Section 301(a) of the Department of Energy Organization Act,
PL 95-91, 91 Stat.
565 at 577-578 (1977),
42 U.S.C.
7151.
(173)(174) "Unrestricted
area" or "uncontrolled area" means any area, access to which is neither
restricted nor controlled by the licensee or registrant.
(174)(175) "User seal
check" or "fit check" means an action conducted by the respirator user to
determine if the respirator is properly seated to the face. Examples include
negative pressure check, positive pressure check, irritant smoke check, or
isoamyl acetate check.
(175)(176) "Very high
radiation area" means an area, accessible to individuals, in which radiation
levels from radiation sources external to the body could result in an
individual receiving an absorbed dose in excess of five gray (five hundred rad)
in one hour at one meter from a source of radiation or from any surface that
the radiation penetrates. At very high doses received at high dose rates, units
of absorbed dose, gray and rad, are appropriate, rather than units of dose
equivalent, sievert and rem.
(176)(177) "Veterinarian"
means an individual licensed by the state of Ohio to practice veterinary
medicine pursuant to Chapter 4741. of the Revised Code.
(177)(178) "Waste" means
those low-level radioactive wastes containing source, special nuclear, or
byproduct material that are acceptable for disposal in a land disposal
facility. For the purposes of this definition, low-level radioactive waste
means radioactive waste not classified as high-level radioactive waste,
transuranic waste, spent nuclear fuel, or byproduct material as defined in
paragraph (A)(26)(b) of this rule, or byproduct material as defined in section
11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat.
919,
42
USC
2014, as amended (2005).
(178)(179) "Week" means
seven consecutive days starting on Sunday.
(179)(180) "Weighting
factor - W
T" for an organ or tissue, (T), is the
proportion of the risk of stochastic effects resulting from irradiation of that
organ or tissue to the total risk of stochastic effects when the whole body is
irradiated uniformly. For calculating the effective dose equivalent, the values
of W
T are:
Organ dose weighting factors
|
Organ or tissue
|
WT
|
Gonads
|
0.25
|
Breast
|
0.15
|
Red bone marrow
|
0.12
|
Lung
|
0.12
|
Thyroid
|
0.03
|
Bone surfaces
|
0.03
|
Remainder
|
0.30a
|
Whole body
|
1.00b
|
\a\0.30 results from 0.06 for each
of five "remainder" organs, excluding the skin and the lens of the eye, that
receive the highest doses.
\b\ for the purpose of weighting the
external whole body dose (for adding it to the internal dose) a single
weighting factor, WT = 1.0, has been specified. The use
of other weighting factors for external exposure will be approved on a
case-by-case basis until such time as specific guidance is issued.
(180)(181) "Whole body"
means for purposes of external exposure, head; trunk, including male gonads;
arms above the elbow; legs above the knee.
(181)(182) "Worker" means
an individual engaged in activities licensed or registered by the department
and controlled by a licensee or registrant, but does not include the licensee
or registrant.
(182)(183) "Working level"
or "WL" means any combination of short-lived radon decay products (for
radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for
radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter
of air that will result in the ultimate emission of 1.3 x
105 million electron volts alpha particle
energy.
(183)(184) "Working level
month" or "WLM" means a cumulative exposure to one working level for one
hundred seventy hours. (Two thousand working hours per year/twelve months per
year equals approximately one hundred seventy hours per month.)
(184)(185) "Year" means
the period of time beginning in January used to determine compliance with the
provisions of this rule. The licensee or registrant may change the starting
date of the year used to determine compliance by the licensee or registrant
provided that the change is made at the beginning of the year and that no day
is omitted or duplicated in consecutive years.